Self-limiting Side Effects Research Articles

Comparison of Ziziphus jujube Mill. Syrup versus polyethylene glycol in children with functional constipation: a randomized clinical trial

Functional constipation is a common disorder of the gastrointestinal tract in children without specific treatment. Ziziphus jujuba has been used in traditional medicine for various diseases such as constipation. A safe and inexpensive treatment with few side effects can be used as an effective alternative to current medications. In this study, we sought to compare Ziziphus jujuba syrup (ZS) with polyethylene glycol (PEG) for the treatment of pediatric functional constipation. A double-blind, randomized clinical trial was performed on children aged 2–10 years with functional constipation who were referred to the gastroenterology clinic of the 17-Shahrivar Hospital in Rasht, Iran. Eligible patients were randomized into two groups: PEG group; 1–5 cc/kg/day (40% w/v solution without electrolytes; average dose: 0.2–1 g/kg), and ZS group; 1–5 cc/kg/day (average dose: 5–25 mg/kg). All patients were followed up for three months, every 2 weeks in the first month, and then monthly for 2 months. At the beginning and end of the study, liver and kidney function tests and blood sugar levels were checked. Data were analyzed using SPSS software version 19 at a significance level of 0.05. Out of 90 eligible children, 32 patients in the PEG group and 30 patients in the ZS group completed the follow-up visits. The mean age of the subjects was 4.31 ± 1.97 years. There was no significant difference between the two groups in terms of age (P = 0.181), gender (P = 0.218), age at onset of constipation (P = 0.083), and weight (P = 0.199). The average therapeutic response score in the ZS group improved prominently compared to the PEG group (P < 0.05). The average number of encopresis and visual analog scale pain scores significantly decreased in the ZS group compared to the PEG group (P < 0.05). Other indices, including frequency of defecation, and medication adherence in the ZS group were significantly improved compared to the PEG group (P < 0.05). Only in the PEG group, a few cases reported self-limiting side effects. ZS can be a treatment choice for functional constipation without any adverse events or liver or kidney injury in children. However, further studies are necessary to find potential side effects.

Optimizing delivery strategies for 3HP TB preventive treatment in Tanzania: A qualitative study on acceptability of family approach in HIV care and treatment centers

Tanzania rolled-out a 12-dose, weekly regimen of isoniazid plus rifapentine (3HP) TB preventive treatment in January 2024. The 3HP completion rate is generally ≥80%, varying by delivery strategy and programmatic setting. Before the roll-out, a mixed methods study was conducted to assess whether a family approach involving family member support, SMS reminders, and three health education sessions was acceptable and optimized 3HP uptake and completion. This paper describes acceptability of the family approach among people living with HIV (PLHIV), treatment supporters (TS), and community health workers (CHWs). This was a qualitative descriptive study in 12 HIV care and treatment centers across six administrative regions. We purposively sampled 20 PLHIV, 12 CHWs for in-depth interviews, and 23 TS for three focus group discussions held between September and December 2023. The theoretical framework of acceptability guided thematic-content analysis using a framework approach. Participants understood that PLHIV have an increased risk for active TB and that 3HP provides shortened treatment for TB disease prevention. They learned about TB and 3HP through health education sessions, but participation of TS was low due to expensive transportation costs to clinics. Receiving support from a trusted person and SMS were perceived as good adherence reminders. The majority reported mild self-limiting side effects but expressed positive attitudes because of the shortened treatment, TB counseling, satisfaction from helping others, lifestyle and work alignment, and reduced work burden. Some PLHIV had difficulties identifying supportive family members, so they chose close friends or CHWs. The family approach to supporting 3HP adherence is widely accepted by PLHIVs, TS, and CHWs in the context of person-centered care that respects their preferences. We recommend its adoption in programmatic settings as a combined approach, considering changes made during the study. However, further research is warranted to assess its acceptance among other populations eligible for 3HP.

Fecal Microbiota Transplantation: A Systematic Review of Therapeutic Potential, Preparation Techniques, and Delivery Methods Across Medical Conditions

Fecal microbiota transplantation (FMT) is revolutionizing the treatment of gastrointestinal disorders by leveraging the gut microbiome in innovative ways. This systematic review evaluates the clinical effectiveness and safety of FMT across various medical conditions, offering insights into its therapeutic potential and limitations. A comprehensive search of PubMed, Web of Science, Scopus, Embase, and ClinicalTrials.gov from January 2000 to December 2023 identified 97 relevant studies on FMT's efficacy, safety, and microbiome changes after eliminating duplicates. FMT has demonstrated high success rates, particularly in treating recurrent and refractory Clostridium difficile infections (CDI), with up to 90% effectiveness, establishing it as a primary treatment for antibiotic-resistant cases. FMT’s applications are expanding to inflammatory bowel diseases (IBD), including ulcerative colitis and Crohn's disease, as well as metabolic disorders and neuropsychiatric conditions. Remission rates for IBD range from 37-45%, with outcomes influenced by donor characteristics, stool preparation, and disease subtype. with mild, self-limiting side effects such as transient diarrhea and abdominal cramping. However, rare serious adverse events underscore the need for rigorous donor screening and standardized preparation protocols to mitigate risks. FMT’s ability to restore healthy gut flora highlights its promise in both gastrointestinal and systemic disease management. However, further research is essential to establish optimized procedures, standardized guidelines, and long-term safety data to facilitate its integration into mainstream medical practice.

Fractional CO2 laser for the treatment of Peyronie's disease: A pilot clinical trial.

Introduction: Fractional CO2 laser therapy is used to treat fibrosing conditions similar to Peyronie’s disease (PD). The aim of the study was to evaluate the safety and efficacy of using a fractional CO2 laser in the management of chronic phase PD. Methods: This was a single-site, non-randomized, open-label study using a fractional CO2 laser. Subjects underwent three treatment sessions every six weeks with a fractional CO2 device. Topical triamcinolone was applied immediately after each treatment. Between treatments, patients performed penile modeling three times daily. Penile curvature assessments, self-reported questionnaires, and adverse event screenings were completed at baseline, 24 weeks, and at 52 weeks. Results: Five patients were included in the study. The median baseline penile curvature was 37.0° (interquartile range [IQR] 33.0°, 53.0°), and at 52 weeks, this had reduced to a median curvature to 28.0° (IQR 17.50°, 44.0°, p=0.03), representing a median reduction in penile curvature by 24.3% (IQR 17.0%, 47.5%). The International Index of Erectile Function Overall scores were comparable at baseline and at 52 weeks (median: 59.0, IQR: 42.5, 66.5 vs. median: 60.0, IQR 53.5, 70.0 respectively, p=0.81). Patients did report significant improvement in overall Peyronies’ disease questionnaire (PDQ) scores from baseline to 52 weeks after laser treatment (median 26.0, IQR15.0, 29.5, vs. median: 14.0, IQR 7.0, 22.50, respectively, p=0.03). Four patients reported self-limiting side effects immediately after laser therapy that resolved spontaneously within two weeks. Conclusions: Fractional CO2 laser therapy may serve as a well-tolerated and minimally invasive therapy for PD in the future, with results at 52 weeks being encouraging.

The Safety Profile of Common COVID-19 Vaccines in Patients With Multiple Sclerosis.

Background and objective Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of coronavirus disease 2019 (COVID-19). In light of the COVID-19 pandemic that emerged in late 2019, the World Health Organization (WHO) has endorsed mass immunization to enhance the population's immunity against the virus. However, certain concerns have been raised about the safety of COVID-19 vaccines among patients with autoimmune disorders, including those with multiple sclerosis (MS). Further research is required to address these concerns and to gain deeper insights into the possible complications of COVID-19 vaccines among MS patients. This study aimed to assess the side effects of COVID-19 vaccines among MS patients. Methods An observational cross-sectional study was conducted between May and November 2023 at the National Guard Hospital, Jeddah, Saudi Arabia. All MS patients enrolled in our local registry system and providedphone numbers were included in the study. A total of 208 MS patients were surveyed via phone interviews, and data were collected regarding their demographics, MS history, COVID-19 history, SARS-CoV-2 vaccination status, and their exposure to disease-modifying therapies (DMTs). All results were analyzed using Stata software. Statistical significance was set at a CI of 95% and a p-value <0.05. Results In our cohort, 128 (61.5%) patients had received three doses of the COVID-19 vaccine, while 68 (32.7%) had received two doses; four patients (2.0%) had received only one dose, five (2.4%) had not received the vaccine, and the number of doses was unknown for the remaining three patients (1.4%). The BNT162b2 mRNA COVID-19 Vaccine from Pfizer-BioNTech was the most commonly administered (n=136 patients, 66.0%),followed byChAdOx1 nCoV-19 Vaccine from Oxford-AstraZeneca (n=47 patients, 22.8%), and mRNA-1273 SARS-CoV-2 Vaccine from Moderna (n=5 patients, 2.4%). Of note, 139 patients (69.5%) reported experiencing adverse events after receiving the vaccine, and the ChAdOx1 nCoV-19 Vaccine from Oxford-AstraZeneca was significantly associated with higher rates of side effects, in 87.8%of the patients. Conclusion A sizable proportion of MS patients experienced self-limiting side effects from exposure to the COVID-19 vaccine. The rates and incidence of side effects were similar to those encountered in the general population. None of the adverse effectsrecorded in our population of MS patients were serious or life-threatening. We recommend thatphysicians encourage patients with MS who have never received COVID-19 vaccinationto get promptly vaccinated as the risks of COVID-19 infectionfar outweigh the minor risks associated with COVID-19 vaccination.

281 Side-effects associated with IV Zoledronic Acid infusion in patients with osteoporosis

Abstract Background Osteoporosis is a common condition affecting bone, leading to fragility and fractures. Oral bisphosphonates are the first line treatment for osteoporosis reducing vertebral, hip and non-vertebral fractures. However poor compliance and Gastro-Intestinal (GI) intolerance result in poor persistence. Intravenous Zoledronic Acid (IV ZA) is an effective alternative therapy, improving compliance and tolerability. Side effects have been reported such as fever, flu-like symptoms, myalgia, arthralgia, headache, uveitis, iritis and hypocalcaemia. Methods This prospective observational study was carried out in a dedicated Bone Health Service. Patients diagnosed with osteoporosis were assessed by the Bone Health team regarding suitability for IV ZA. Infusions were administered in a nurse-led IV ZA clinic. Pre and 1-week post infusion bloods including Renal, Liver and Bone profile, Parathyroid hormone, Vitamin D and bone markers- Osteocalcin, CTX, PINP were taken. Side effects post infusion were recorded. Results N = 189. 161:28 female to male ratio. Age range 32-90 years, median 61 years. All diagnosed with osteoporosis in hip and/or spine. Forty-three percent were bisphosphonate naïve. 51 (27%) attended GP for post infusion bloods while 7 patients received infusion while inpatients. 29% of those returning to clinic for post infusion bloods reported side effects. Treatment naïve and treatment experienced reported similar rate of side effect 21%/20% respectively. Most common side effects include flu-like symptoms (31%) with fatigue/tiredness/generalised aches and pains/GI upset 16% respectively. 10% reported headaches while 5% experienced sore/swollen eyes. Rash, swollen joints and pre-syncope experienced by 3% respectively. Symptoms resolved after 24-48 hrs. Conclusion IV ZA is a well-established treatment for osteoporosis particularly for patients intolerant or poorly compliant with oral bisphosphonate therapy and an accepted treatment to close-off Denosumab. According to our study IV ZA is well tolerated with self-limiting side effects. However, pre infusion screening is essential to deem suitability.

A single infusion of intravenous lidocaine for primary headaches and trigeminal neuralgia: a retrospective analysis.

Intravenous (IV) lidocaine has been used as a transitional treatment in headache and facial pain conditions, typically as an inpatient infusion over several days, which is costly and may increase the risk of adverse effects. Here we report on our experience using a single one-hour IV lidocaine infusion in an outpatient day-case setting for the management of refractory primary headache disorders with facial pain and trigeminal neuralgia. This is a retrospective, single-center analysis on patients with medically refractory headache with facial pain and trigeminal neuralgia who were treated with IV lidocaine between March 2018 and July 2022. Lidocaine 5 mg.kg-1 in 60 mL saline was administered over 1 h, followed by an observation period of 30 min. Patients were considered responders if they reported reduction in pain intensity and/or headache frequency of 50% or greater. Duration of response was defined as short-term (< 2 weeks), medium-term (2-4 weeks) and long-term (> 4 weeks). Forty infusions were administered to 15 patients with trigeminal autonomic cephalalgias (n = 9), chronic migraine (n = 3) and trigeminal neuralgia (n = 3). Twelve patients were considered responders (80%), eight of whom were complete responders (100% pain freedom). The average duration of the treatment effect for each participant was 9.5 weeks (range 1-22 weeks). Six out of 15 patients reported mild and self-limiting side effects (40%). A single infusion of IV lidocaine might be an effective and safe transitional treatment in refractory headache conditions with facial pain and trigeminal neuralgia. The sustained effect of repeated treatment cycles in some patients may suggest a role as long-term preventive therapy in some patients.

Dapoxetine versus glans penis injection with hyaluronic acid gel in treatment of premature ejaculation

ABSTRACT Objective to compare the results of using Dapoxetine and HA (hyaluronic acid) gel injection by Five puncture technique in the treatment of premature ejaculation (PE). Methods 100 sexually active heterosexuals circumcised males with lifelong PE were included in the study. Group A patients were treated with on-demand Dapoxetine, while group B was treated with HA gel glans penis injection using a five-puncture technique. Both groups were evaluated at 1st,3rd and 6th months post-treatment using IELT. Results There were no significant differences between both groups regarding patient demographic. Mean pretreatment IELT in groups A and B were 45.82 ± 7.44 and 46.18 ± 7.82 receptively. There was no significant difference between both groups. After treatment, both groups show significant ILET improvement during the 1st,3rd, and 6th months follow-up with a P value < 0.001. However, when comparing the improvement of ILET in group A (Dapoxetine) and group B (HA injection), there were high significance differences in favor of group B in the 1st,3rd, and 6th-month follow-up. Conclusion Although both treatment modalities have improved IELT and premature ejaculation, but HA injection with five punctures technique was significantly better than oral Dapoxetine with self-limited side effects.

Side Effects With a Focus on Lymphadenopathy Following COVID-19 Vaccination in Pediatric and AYA Oncology Patients.

The Coronavirus Disease 2019 (COVID-19) pandemic led to the swift development of multiple vaccinations. Vaccine side effects were well-documented in the healthy adult cohort and included fever and lymphadenopathy, however, side effects in the pediatric immunocompromised population have not been reported. This retrospective study investigated vaccine-eligible children and adolescent young adult oncology patients 12 to 35 years old. We found uncommon, mild, and self-limiting side effects among pediatric cancer patients and survivors. This data will help guide pediatric and AYA oncologists in providing anticipatory guidance and serve as a guide to managing lymphadenopathy as a potential confounder of malignancy.

Side effects of Pfizer/BioNTech (BNT162b2) COVID-19 vaccine reported by the Birzeit University community

BackgroundThe Pfizer BioNTech COVID-19 vaccine was the first to receive emergency authorization and approval from the FDA. Therefore, it is preferred by most recipients; however, many people are concerned about the vaccine’s side effects. At the time of the study, December 2021, Palestine lacked a national reporting system for monitoring adverse vaccine effects. Therefore, this study investigates the post-vaccine adverse events following the Pfizer/BioNTech COVID-19 Vaccine administration in Palestine and identifies the occurrence, extent, and severity among university staff, employees, and students at Birzeit University.MethodA questionnaire-based retrospective cross-sectional study was conducted using a university website (Ritaj), social media platforms (e.g., Facebook and Telegram), and in-person interviews. The Chi-square, Fisher’s exact, and McNemar’s tests were used to investigate significant relationships. Data were analyzed using SPSS version 22.ResultsIn total, 1137 participants completed the questionnaire, 33.2% were males, and the mean age was 21.163 years. All participants received at least one dose of the Pfizer-BioNTech COVID-19 vaccine. Approximately one-third of participants reported no adverse effects after receiving the first, second, or third doses (34%, 33.6%, and 32.5%, respectively). The most commonly reported adverse events were fever, chills, headache, fatigue, pain and swelling at the injection site, muscle pain, and joint pain. Allergic reactions were reported by 12.7% of the participants; furthermore, participants with a history of allergy or anaphylaxis before vaccination had a significantly higher tendency for post-vaccination allergic reactions. Eight participants reported rare side effects, including 7 (0.6%) cases of thrombocytopenia and one (0.1%) case of myocarditis. Males aged less than 20 years and smokers were significantly less likely to complain of adverse events. The number of reported side effects was significantly higher after the second vaccine dose than after the first dose. Finally, participants infected with COVID-19 before vaccination was significantly associated with side effects such as fever, chills, shortness of breath, and persistent cough.ConclusionIn this study, the most common post- BNT162b2 Vaccination reported self-limiting side effects similar to those reported by Pfizer/BioNTech Company. However, higher rates of allergic reactions were reported in this sample. Rare side effects, such as thrombocytopenia and myocarditis, were reported by 8 participants. COVID vaccines have been developed at an accelerated pace, and vaccine safety is a top priority; therefore, standard monitoring through a national adverse event reporting system is necessary for safety assurance. Continuous monitoring and long-term studies are required to ensure vaccine safety.

The acceptability of antidepressant treatment in people living with HIV in Malawi: A patient perspective

ABSTRACT Depression is common among people living with HIV (PLWH). Measurement-based care models that measure depression severity and antidepressant side effects, and use an algorithm to guide antidepressant prescription by non-specialized health workers represent an evidence-based treatment for severe depression in sub-Saharan Africa. We conducted in-depth interviews from June to December 2018 with eleven patients enrolled in Project SOAR-Mental Health, a pilot project integrating depression treatment into HIV care in Malawi. Patients treated with amitriptyline or fluoxetine participated in interviews exploring antidepressant acceptability through patient knowledge, side effect severity, pill burden, adherence, perceived efficacy, and tolerability. Patients described a lack of detailed antidepressant education from their providers. Variable, typically self-limiting side effects were reported from both amitriptyline and fluoxetine. While most side effects were mild, three patients reported functional impairment. Patients reported high adherence, though the additional pill burden was a challenge. Most patients found the antidepressants efficacious, tolerable, beneficial and acceptable. Although patient psychoeducation is notably lacking as a facet of clinical management, antidepressant prescription by primary care providers appears acceptable for comorbid severe depression in PLWH initiating HIV care in sub-Saharan Africa. Health workers should be mindful of dosing to minimise side effects and considerate of the additional pill burden. Trial registration: ClinicalTrials.gov ID [NCT03555669]. Retrospectively registered on 13 June 2018.

Evaluation of Short-Term Side Effects Following the First Dose of COVID-19 Vaccines Among Physicians and Dentists: A Cross-Sectional Study from India.

Efficacy and safety are fundamental for the development of successful COVID-19 vaccines. Vaccine-associated side effects influence vaccine hesitancy. This study investigated the prevalence, severity, and onset of side effects following the first dose of COVID-19 vaccines among physicians and dentists working in various healthcare settings across India. A cross-sectional survey collected self-report data from April to June 2021 on side effects following the first dose of the vaccine. An online validated questionnaire using the Google Docs® platform was circulated via email and social media platforms. More than 40% of participants experienced at least one side effect after the first dose of vaccination; the most common were mild and resolved within three days after vaccination. More than 91% of respondents received the Covishield (AstraZeneca) vaccine; the most prevalent adverse effects were soreness of the injected arm (78.9%), tiredness (71.1%), and fever (54.9%). Logistic regression showed that women were almost 60% less likely to report side effects. Findings supported the safety of the first dose of the COVID-19 vaccine based on relatively few self-limiting side effects, mainly soreness of the injected arm and tiredness. Further research is needed to determine the long-term safety of COVID-19 vaccines, especially after booster doses.

Improvement of fibroid-associated symptoms and quality of life after US-guided high-intensity focused ultrasound (HIFU) of uterine fibroids

Uterine fibroids are the most common benign uterine tumors and can cause various severe symptoms as abnormal menstrual bleeding or pelvic pain. Therefore, the primary objective in the treatment of uterine fibroids is a sufficient symptom relief. Ultrasound (US)-guided High-intensity focused ultrasound (HIFU) is an effective non-invasive treatment strategy for ablation of uterine fibroids that can achieve a significant tumor volume reduction. The aim of the study is to evaluate if US-guided HIFU treatment can reduce fibroid-associated symptoms leading to an improvement of health-related quality of life. Fifty-five women with symptomatic uterine fibroids underwent US-guided HIFU ablation. Clinical evaluation was performed on the basis of the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) at baseline, 6 weeks, 3, 6, 9 and 12 months after HIFU. Imaging follow-up included contrast-enhanced ultrasound (CEUS) and contrast-enhanced MRI. A significant reduction of the Symptom Severity Scale (SSS) was observed between 6 weeks and 12 months after HIFU (49.9 ± 19.4 at baseline vs. 42.2 ± 20.1 at 6 weeks and 23.6 ± 12.7 at 12 months after treatment, p < 0.001) correlating with a significant improvement (p < 0.001) of Health-related Quality of Life (HRQL) (52.5 ± 22.7 at baseline vs. 59.8 ± 22 at 6 weeks and 77.9 ± 17.3 at 12 months after treatment). Significant postinterventional improvement was observed in every subscale of HRQL. In the majority of patients, only minor, short-lasting and self-limiting side effects were observed, e.g. soft tissue edema of the anterior lower abdominal wall in the acoustic pathway or transient moderate lower abdominal pain as during menstruation. One patient with a very large fibroid experienced strong short-lasting pain after the procedure; two patients experienced post-procedurally a transient sciatic nerve irritation. US-guided HIFU of uterine fibroids reduces disease-related symptoms and improves health-related quality of life.

Safety and efficacy of cathodal transcranial direct current stimulation in patients with Lennox Gastaut Syndrome: An open-label, prospective, single-center, single-blinded, pilot study

PurposeLennox-Gastaut Syndrome (SLG) is a severe form of childhood refractory epilepsy. Only one pilot study has been conducted using cathodal transcranial direct current stimulation (c-tDCs; 2mAx30minx5days) in LGS with promising results (-99% seizure reduction at 5 days). Our aim was to explore and replicate the efficacy and safety of 10 daily sessions of c-tDCs in SLG. MethodsWe conducted a one-blinded, single-center pilot clinical study of c-tDCs (2mAx 30 min x 10 days), applied over the highest amplitude or frequent epileptiform interictal discharges areas using scalp EEG recordings without changes in their treatments. The tDCS device used was Enobio EEG® (Neuroelectrics, Barcelona, Spain). The primary outcome was based on the seizure frequency using seizure diaries before, during 10 days of treatment, and then on a 4 and 8 weeks of follow-up. The rate of adverse events was recorded as a secondary outcome. Descriptive statistics and Wilcoxon signed-rank test were used ResultsTwenty-four patients were enrolled. The mean age was 10.1 ± 5.8 years old and 75% male. All the patients had severe mental retardation and abnormal neurological examinations. A significant median percentual seizure frequency reduction was found: 68.12% (p = 0.05) at 1 week, 68.12% (p = 0.002) in the second week. We found no significant reduction at 1 and 2 months; mainly tonic and atonic seizures were reduced significantly at all times. Only mild self-limited side effects were recorded mainly itching and erythema in the application zone ConclusionTen sessions of c-tDCs in combination with pharmacologic treatment in LGS is safe and appears to reduce significatively tonic and atonic seizure frequency at 2 months of follow-up.

EFFICACY OF ARMODAFINIL IN PATIENTS WITH MODERATE TO SEVERE OSA AND RESIDUAL EXCESSIVE DAYTIME SLEEPINESS AFTER SUBOPTIMAL USAGE OF CPAP TREATMENT

TYPE: Late Breaking Abstract TOPIC: Sleep Disorders PURPOSE: Large number of obstructive sleep apnea (OSA) patients treated with continuous positive airway pressure (CPAP) still experienced excessive daytime sleepiness (EDS), which affects quality of life and may discourage CPAP treatment. Armodafinil, wakefulness promoting agent, is approved for treating EDS in OSA patients who still experience EDS despite adequate CPAP usage. To date, there are no studies investigating effectiveness of early administration of Armodafinil with suboptimal CPAP usage. METHODS: A 12-week prospective cohort study was conducted on 30 OSA patients with suboptimal CPAP usage (2-<4 hours/night) who still experienced EDS. All patients received 150-mg Armodafinil daily and continued using CPAP. Efficacy and side effects were evaluated. RESULTS: 17/30 patients were analyzed for preliminary results after 4 weeks of Armodafinil therapy. Epworth Sleepiness Scale (ESS) was significantly decreased from 13±2.72points at baseline therapy to 6.40±3.50 points (p<0.001). Clinical Global Impression (CGI) rated by investigator and by patients were significantly decreased from 3.73±0.70 to 1.73±0.45 (p<0.001) and decreased from 3.35±0.63 to 1.78±0.57 (p<0.001); respectively. Pittsburg Sleep Quality Index (PSQI) was also significantly decreased from 9.67±3.99 to 6.13±3.06 (p<0.001). No serious side effects were observed. CONCLUSIONS: This is the first study conducted in moderate to severe OSA patients with residual EDS after suboptimal usage of CPAP treatment, in which administration of Armodafinil for 4-week- period was generally well tolerated with mild and self-limiting side effects. Armodafinil significantly reduced daytime sleepiness and improved sleep quality. Efficacy of Armodafinil at 12- week-period will be further analyzed. CLINICAL IMPLICATIONS: Early administration of Armodafinil can decrease EDS in subopimal CPAP usage patients. DISCLOSURE: No significant relationships. KEYWORD: Excessive daytime sleepiness

Drug-induced esophagitis and helpful management for healthcare providers.

In recent decades, the number of cases developing drug-induced esophagitis (DIE) has reportedly been growing, which indicates the significance of detecting medicines capable of causing this adverse reaction. This study aims to provide an updated review on recent case reports of DIE, to evaluate the possible mechanism of this side effect, and to provide helpful management. Data was gathered through searches of three databases, namely PubMed, Medline, and Cochrane. Seven drug categories were evaluated: antibiotics, bisphosphonates, cardiovascular medicines, chemotherapeutic agents, non-steroidal anti-inflammatory drugs (NSAIDs), other medications, and supplements. According to the findings, retrosternal pain, heartburn, odynophagia, and dysphagia are typical symptoms of DIE, and in most cases, DIE is a self-limiting side effect which can be resolved by removing the causative agent and providing supportive therapy.

Probiotics Efficacy and Safety as add-on Therapy to Metformin in Type 2 Diabetes Mellitus

Background: Insulin secretion is decreased, and peripheral insulin sensitivity is diminished, resulting in type 2 diabetesmellitus. Diet, oral antihyperglycemic medications, and insulin are all modalities for treatment.Objective: The goal of this study was to compare the efficacy of probiotics as an add-on treatment to metformin inpatients with Type 2 Diabetes Mellitus.Methods: The study participants were randomly allocated to one of two groups, Group A or Group B, using a computergeneratedrandomization chart, with each group consisting of 75 patients. Group A - For 12 weeks, patients in this groupwere administered Tab. Metformin 500 mg twice daily with meals. Group B - For 12 weeks, patients in this group wereadministered Tab. Metformin 500 mg twice daily with meals and Cap. Probiotics 1 capsule twice daily with meals. At theculmination of the second, fourth, eighth, and twelfth weeks, all patients were evaluated. Fasting and postprandial bloodglucose levels were measured at each visit. The HbA1c test was performed at the end of the 12th week.Results: The male predominance was seen with males 57% and females 43% in the group A and the male : female ratiowas 1.34:1. In Group B males were 55% and females were 45%. The male: female ratio was 1.20 : 1. The mean HbA1Cslightly reduced since the start till the end of the study. A total of 37% of the patients experienced minor self-limiting sideeffects in group A as compared to 6.66% of Group – B.Conclusion: In treatment for type 2 diabetes mellitus, probiotics as an add-on therapy with metformin was observedto lower fasting blood glucose, postprandial blood glucose, and HbA1c levels when compared to metformin alone. Interms of effectiveness, probiotics have shown no substantial significant outcomes in combination therapy. However, theprobiotics study group had fewer reported gastrointestinal adverse effects associated with metformin treatment.

Bothersome Hematospermia Following Stereotactic Body Radiation Therapy for Prostate Cancer.

BackgroundHematospermia following prostate radiation therapy is a benign and often self-limiting side effect. However, it may be bothersome to some men and their partners with a negative impact on sexual quality of life (QOL). This study sought to evaluate the incidence, duration, and resolution of hematospermia in patients following stereotactic body radiation therapy (SBRT) for prostate cancer.Methods227 patients treated with SBRT from 2013 to 2019 at Georgetown University Hospital for localized prostate carcinoma with a minimum follow up of two years were included in this retrospective review of data that was prospectively collected. Patients who were greater than 70 years old and/or received hormonal therapy were excluded. Hematospermia was defined as bright red blood in the ejaculate. Time points for data collection included initial consultation, pre-treatment, 1-, 3-, 6-, 9-, 12-, 18-, 24-month. All patients were treated with the CyberKnife Radiosurgical System (Accuray). Data on hematospermia including duration, resolution and recurrence was collected. Utilization of 5-alpha reductase inhibitors was documented at each visit.Results227 patients (45 low-, 177 intermediate-, and 5 high-risk according to the D’Amico classification) at a median age of 65 years (range 47-70) received SBRT for their localized prostate cancer. The 2-year cumulative incidence of hematospermia was 5.6%(14 patients). For these patients, all but one patient (93%) saw resolution of their hematospermia by two years post-SBRT. The median time for hematospermia was 9 months post-treatment. Of the 14 patients who reported hematospermia, 70% were managed with 5-alpha reductase inhibitors. Hematospermia was transient in most patients with 70% of the men reporting resolution by the next follow-up visit.ConclusionThe incidence of bothersome hematospermia following SBRT was low. Hematospermia, as noted by other studies, often self-resolves. 5-alpha reductase inhibitors may lead to quicker resolution of bothersome hematospermia.

AVM0703 Tumor Debulking Enhances Cy/Flu Efficacy

AVM0703 is a high concentration (24 mg/mL) dexamethasone phosphate drug product that permits the safe administration of the doses necessary to mobilize gamma delta+, bi-specific natural killer T (NKT) cells. AVM0703 is in clinical trials as a stand-alone treatment for relapsed/refractory (R/R) Non-Hodgkin's Lymphoma (NHL). Even more exciting is the potential combination of AVM0703 with standard chemotherapy to reduce the number of treatment cycles while maintaining efficacy. A therapeutic solution that reduces the number of chemotherapy cycles could lower the risk of secondary malignancies, decrease long-term toxicities, and limit costs associated with management of chemotherapy toxicities. AVM0703 has been well tolerated to date, with mild to moderate and self-limiting side effects. This indicates the use of AVM0703 in combination therapies may greatly improve quality of life for patients during treatment.AVM0703 has been tested in an aggressive mouse B-cell lymphoma model (A20) alone and in combination with cyclophosphamide/fludarabine (CyFlu). The tumor killing effect of AVM0703 on A20 cells in Matrigel TM embedded tumors is evident as early as 3 hours after dosing, assessed by flow cytometry. Maximum A20 cell death is observed 24 hours after treatment in blood (Figure 1) and between 3- and 24-hours in tumors (Figure 2). Treatment with AVM0703 alone was compared with Cy/Flu alone and with a combination of single dose AVM0703 followed by one Cy/Flu cycle. Tumor growth was monitored by caliper measurements and blood and tumors were analyzed by flow cytometry at the end point, 7-days after Cy/Flu dosing. AVM0703 alone was superior to one cycle of Cy/Flu and the combination of a dose of AVM0703 followed by Cy/Flu was the most effective (Figure 3). Of the mice treated with the combination, 33% had no visible tumor 7-days post-dose. We are currently testing AVM0703 administered between 6- and 24-hours before a single Cy/Flu dose and predict that A20 eradication should be more complete in all compartments. Acute 7 day studies will be followed by long-term studies to evaluate A20 tumor escape or recurrence. In previous studies with long term monitoring of tumor growth, AVM0703 administered 3 days before one cycle of Cy/Flu induced long-term stable disease up to 50 days in tumor bearing mice (Figure 4a) compared to two cycles of Cy/Flu where 33% of the tumors escaped (Figure 4b). Additional studies in combination with R-CHOP are underway.AVM0703 has the ability to debulk the tumor by mobilizing gamma delta+, bi-specific natural killer T (NKT) cells. When added to a chemotherapeutic regimen, the chemotherapy may be more effective due to the lower tumor burden in the body. As cancer survivors live longer, the late term consequences of chemotherapy have become apparent, which include secondary malignancies. The challenge for new treatments is to reduce toxicities without sacrificing efficacy. AVM0703 has the potential to be one solution when used in combination with chemotherapy. Future clinical trials will determine if debulking with AVM0703 results in a reduction of the number of necessary R-CHOP cycles while maintaining or enhancing the efficacy rate. [Display omitted] DisclosuresDeisher: AVM Biotechnology, LLC: Current Employment. Sawas: AVM Biotechnology, LLC: Current Employment. Suwito: AVM Biotechnology, LLC: Current Employment. Rylatt: AVM Biotechnology, LLC: Current Employment. Jarzyna: AVM Biotechnology, LLC: Current Employment. Zahid: AVM Biotechnology, LLC: Ended employment in the past 24 months. Parthasarathy: AVM Biotechnology, LLC: Consultancy, Ended employment in the past 24 months. Poulin: AVM Biotechnology, LLC: Current Employment. Lee-Diaz: AVM Biotechnology, LLC: Current Employment.

The Safety and Efficacy of Repetitive Transcranial Magnetic Stimulation in the Treatment of Major Depression Among Children and Adolescents: A Systematic Review.

Major depression is a chronic debilitating condition affecting people of all ages and is rising over the past decade. Major depression among children and adolescents is often resistant to traditional treatments, thus necessitating the exploration of novel strategies. Repetitive transcranial magnetic stimulation (rTMS) is gaining increasing attention as a useful tool in treating various conditions and has received the US Food and Drug Administration (FDA) approval to treat depression and obsessive-compulsive disorder among adults. Favorable outcomes among adults generated interest in using it among children. Until recently, the existing literature lacked randomized sham-controlled trials on this topic among children and adolescents. The newest additions in the literature necessitated another in-depth look at the data to explore the safety and efficacy of rTMS in the context of depression among children and adolescents. We searched the Medline and Cochrane databases and included 18 articles for our systematic review. Our systematic review indicates level 1 evidence that rTMS is safe but failed to show its superiority to placebo as a stand-alone treatment for resistant depression among children and adolescents. However, there is level 2 evidence favoring add-on rTMS to treat major depression among children and adolescents. The study subjects appear to tolerate the rTMS treatment well with some minor and mostly self-limited side effects. Risks of treatment-emergent hypomanic symptoms and seizure appear to be very low. There is no evidence of worsening of suicidal ideation or cognitive decline during rTMS treatment.